Tools - FPS

Basic Information

• Brand Name: Tools - FPS
• Primary DI: 00842188121470
• Version / Model: RMRFPSC-22
• Catalog Number: RMRFPSC-22
• Company Name: TRIMED, INCORPORATED
• Labeler DUNS: 138041277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-20
• Public Version: 6
• Public Version Date: 2023-10-17
• Public Version Status: Update
• Public Device Record Key: 11b28e84-f109-4eba-82fe-f9f05e311751

Device Description

FPS Cone Reamer, 22mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTO	REAMER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61807	Bone-resection orthopaedic reamer, single-use	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842188121470	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]